Magnetic compression anastomosis device

ABSTRACT

An apparatus for joining organ wall portions of first and second hollow organs, including first and second connectors, wherein the first and second connectors are magnetically attracted to one another. A device for delivering and deploying the first and second connectors to portions of the first and second hollow organs can be provided, wherein the device is configured and dimensioned to axially align the first and second connectors for performing circular anastomosis of the first and second hollow organs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/175,353, filed Feb. 7, 2014, now U.S. Pat. No. 8,920,446, which is acontinuation of U.S. patent application Ser. No. 12/486,846, filed Jun.18, 2009, now U.S. Pat. No. 8,685,046, which claims priority from andbenefit of Provisional Patent Application Ser. No. 61/086,340, filedAug. 5, 2008,the disclosures of each of the above identifiedapplications are hereby incorporated by reference in the entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to a surgical device for treating holloworgans and, more particularly, to a surgical device suitable forperforming circular anastomosis of hollow organs.

2. Discussion of Related Art

Anastomosis is the surgical joining of separate hollow organ sections.The site of the attachment is also sometimes called an anastomosis.Typically, an anastomosis procedure follows surgery in which a diseasedor defective section of a hollow organ is removed and the remaining endsections are to be joined. Depending on the desired anastomosisprocedure, the sections may be joined by end-to-end, end-to-side orside-to-side organ reconstruction methods. End-to-end anastomosis isgenerally performed using surgical staples.

The staples are usually left in the patient. In a circular stapledanastomosis procedure, the two ends of the organ sections are joined bymeans of a stapling instrument which drives a circular array of staplesthrough the organ end sections and simultaneously cores and removes anytissue located interior of the driven circular array of staples to freea tubular passage.

In some applications of a circular anastomosis procedure, an anvil rodhaving an attached anvil head is mounted to the distal end of a surgicalstapling instrument shaft prior to insertion of the instrument into thetissue to be anastomosed. However, in other applications, it ispreferable to utilize a detachable anvil rod which may be mounted to theinstrument subsequent to positioning of the instrument and the anvilassembly within respective tissue sections. In such instances, thestapling instrument and the anvil assembly are separately delivered tothe operative site. Each tissue section is secured to a respective anvilor staple holding component by a purse string suture. The anvil assemblyis mounted to the stapling instrument by inserting a mounting portion ofthe anvil rod within the distal end of the instrument so that a mountingmechanism within the instrument securely engages the rod.

FIG. 1 illustrates a surgical stapling instrument for performingcircular anastomosis of hollow organs. Referring to FIG. 1, the staplingdevice 10 includes a proximal handle assembly 12, an elongated centralbody portion 14 including a curved elongated outer tube 14 a, and adistal head portion 16. Handle assembly 12 includes a stationary handle18, a firing lever 20, a rotatable approximation knob 22 and anindicator 24. Indicator 24 includes indicia, such as color coding oralpha-numeric labeling, to identify to a surgeon whether the device isapproximated and is ready to be fired. Head portion 16 includes a stapleholding component (cartridge) 31 and an anvil assembly 30 including ananvil rod 52 with attached anvil head 63. Opposed end portions of tissueto be stapled are clamped between the anvil head 63 and the stapleholding component 31. The clamped tissue is stapled by driving one ormore staples from the staple holding component 31 so that the ends ofthe staples pass through the tissue and are deformed by the anvilpockets of anvil head 63.

Methods and devices for forming anastomoses between hollow anatomicalstructures using magnetic force have been proposed. However, many of theproposed anastomotic couplings are simply too cumbersome and difficultto deliver or deploy.

It would be beneficial to provide a surgical device for performingcircular anastomosis of hollow organs utilizing magnetic force that iseasy to use and produces a reliable anastomosis, placing the holloworgans in flow communication.

SUMMARY

According to an exemplary embodiment of the present disclosure, anapparatus for joining organ wall portions of first and second holloworgans is disclosed. The apparatus includes first and second connectors,wherein the first and second connectors are magnetically attracted toone another. A device for delivering and deploying the first and secondconnectors to portions of the first and second hollow organs is alsodisclosed, wherein the device is configured and dimensioned to axiallyalign the first and second connectors for performing circularanastomosis of the first and second hollow organs.

In one embodiment, the first connector has a proximal facing surface andthe second connector has a distal facing surface, the proximal facingsurface having a first polarity and the distal facing surface having adifferent polarity.

In one embodiment, the first connector has a proximal facing surface andthe second connector has a distal facing surface, the proximal facingsurface having regions of different polarity and the distal facingsurface having regions of different polarity. The regions of differentpolarity can comprise alternating regions of different polarity. Thedistal facing surface of the second connector can have regions ofdifferent polarity.

In another aspect, an apparatus for joining organ wall portions of firstand second hollow organs is disclosed. The apparatus comprises first andsecond connectors, the first connector having a proximal facing surfaceand the second connector having a distal facing surface. The proximalfacing surface of the first connector has regions of different polarityand the first and second connectors are magnetically attracted to oneanother. In one embodiment the distal facing surface of the secondconnector has regions of different polarity. In one embodiment, thefirst and second connectors are substantially ring-shaped. In oneembodiment the distal facing surface and proximal facing surfacecomprise alternating regions of different polarity such that on theproximal facing surface there are at least two regions of a firstpolarity and at least one region of a second polarity and on the distalfacing surface there are at least two regions of the second polarity andat least one region of the first polarity.

In another aspect of the present disclosure, an apparatus for joiningorgan wall portions of first and second hollow organs includes a firstconnector capable of producing a magnetic field, a second connectorcapable of producing a magnetic field, and a device for delivering anddeploying the first and second connectors to end portions of the firstand second hollow organs. The device is configured and dimensioned toaxially align the first and second connectors for forming an anastomosisthat places the first and second hollow organs in flow communication.The device includes: a handle portion; a neck portion supported on adistal end of the handle portion, wherein the neck portion is configuredto releasably house the second connector; and a head portion including arod, the rod extending axially outward from a proximal end of the headportion and configured to be detachably mountable to a distal end of theneck portion, wherein the first connector is detachably affixed to thehead portion.

BRIEF DESCRIPTION OF THE DRAWINGS

Objects and features of the presently disclosed magnetic compressionanastomosis device will become apparent to those of ordinary skill inthe art when descriptions of various embodiments thereof are read withreference to the accompanying drawings, of which:

FIG. 1 is a top side perspective view of a prior art surgical staplingdevice in the unapproximated position;

FIG. 2 is a perspective view of a magnetic compression anastomosisdevice, according to an exemplary embodiment of the present disclosure;

FIG. 2A is a perspective view of the anastomosis instrument for applyingthe magnetic compression anastomosis device.

FIG. 3 is a cross-sectional view of the magnetic compression anastomosisdevice illustrated in FIG. 2;

FIG. 4A is a perspective view of an anastomotic connector, according toan exemplary embodiment of the present disclosure;

FIG. 4B is a perspective view of an anastomotic connector, according toan exemplary embodiment of the present disclosure;

FIG. 5A is a perspective view of an anastomotic connector, according toan alternate embodiment of the present disclosure;

FIG. 5B is a perspective view of an anastomotic connector, according toan alternate embodiment of the present disclosure;

FIG. 6A is an exploded view illustrating two anastomotic connectorassemblies having inner and outer connector members, according toanother embodiment of the present disclosure;

FIG. 6B is a cross-sectional view of organ wall portions of two holloworgans showing the axially-aligned anastomotic connector assembliesshown in FIG. 6A;

FIG. 6C is a cross-sectional view of organ wall portions of two holloworgans showing two axially-aligned anastomotic connector assemblies,according to another alternate embodiment of the present disclosure;

FIG. 6D is a cross-sectional view of organ wall portions of two holloworgans showing two axially-aligned anastomotic connector assemblies,according to yet another alternate embodiment of the present disclosure;

FIG. 7A is a perspective view of a rod of a head portion of a magneticcompression anastomosis device, according to one embodiment of thepresent disclosure;

FIG. 7B is a perspective view of an alternate embodiment of a rod of ahead portion of a magnetic compression anastomosis device;

FIG. 7C is a perspective view of another alternate embodiment of a rodof a head portion of a magnetic compression anastomosis device;

FIG. 8 is a cross-sectional view showing the head and neck portions ofthe magnetic compression anastomosis device illustrated in FIGS. 2 and 3separately delivered to two organ end sections, according to anexemplary embodiment of the present disclosure;

FIGS. 9-11 are cross-sectional views of the magnetic compressionanastomosis device illustrated in FIGS. 2 and 3 showing the deploymentof axially-aligned anastomotic connectors, according to exemplaryembodiments of the present disclosure; and

FIG. 12 is a cross-sectional view of organ wall portions of two holloworgans showing the anastomotic connectors of FIG. 11 falling free as aresult of tissue necrosis, according to an exemplary embodiment of thepresent disclosure.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

Hereinafter, exemplary embodiments of the presently disclosed magneticcompression anastomosis device will be described with reference to theaccompanying drawings. Like reference numerals may refer to similar oridentical elements throughout the description of the figures. As usedherein, the phrase “magnetic material” refers to any material capable ofproducing a magnetic field or any material that reacts to or is affectedby a magnetic field.

In various exemplary embodiments, the presently disclosed magneticcompression anastomosis device includes first and second connectors,which are magnetically attracted to one another, and a delivery anddeployment device configured and dimensioned to axially align the firstand second connectors to facilitate the formation of an anastomosisbetween the two end portions of the organ sections to be joined.

FIGS. 2 and 3 illustrate a magnetic compression anastomosis deviceaccording to an exemplary embodiment. The magnetic compressionanastomosis device 200 includes a neck portion 220 of magnetic holdingcomponent 31′ extending from an elongated central body portion 14′(having a curved elongated outer tube 14a′ shown in FIG. 2A), which issupported on an end of a handle assembly 12′, a head portion 210, afirst connector 255 detachably affixed to the head portion 210, and asecond connector 265 releasably housed in the neck portion 220. In anexemplary embodiment of the presently disclosed magnetic compressionanastomosis device, the first connector 255 is substantially the same asthe first anastomotic connector 401 shown in FIG. 4A and the secondconnector 265 is substantially the same as the second anastomoticconnector 402 shown in FIG. 4B.

Neck portion 220 includes an actuator or center rod 240 and a sleeveportion 260 at the distal end of the neck portion. The sleeve portion260 releasably houses the second connector 265. The actuator shaft 240is movable in relation to the sleeve portion 260 between a firstretracted position and a second extended position by for example arotation knob 22′ (FIG. 2A). When the actuator 240 is in the secondposition, the head portion 210 is engageable and disengageabletherefrom. Moving the actuator 240 to the first position (also referredto herein as “approximated position”) approximates the two portions andprevents disengagement of the head portion 210 from the actuator 240.This can be achieved in various ways such as by providing springstructure (not shown) associated with the actuator 240 which engages therod 230 and its movement is inhibited when the actuator 240 is retractedwithin neck 220. An example of such structure is disclosed in U.S. Pat.No. 7,303,106, the entire contents of which are incorporated byreference herein. The handle portion (not shown) may include anindicator 24′ to provide an indication to a surgeon that the headportion 210 has been unapproximated a distance sufficient to allowremoval of the head portion 210 from the actuator 240 or, alternatively,that any further unapproximation of the head portion 210 will move thehead portion 210 to a position in which the head portion 210 can bedisengaged from actuator 240. An example of an indicator which can beutilized is the indicator of U.S. Patent No. 7,303,106, incorporatedherein in its entirety by reference. Sleeve portion 260 defines a sleevebody having a retaining portion defining a retaining body having alongitudinal throughbore dimensioned to slidably receive the secondconnector 265 therein.

Head portion 210 includes a knife 215 and a rod 230 extending from aproximal portion. Rod 230 extends axially outward from an end of thehead portion 210 and includes a proximal end portion which is receivedwithin and engages a mounting mechanism (not shown) within the actuator240 at a distal portion of the neck portion 220. The proximal endportion of the rod 230 may include a generally conical shaped mountingportion that is advantageously dimensioned to facilitate entry withinthe actuator 240 and which further enables manipulation of rod 230through body tissue. It is to be understood that the proximal endportion of the rod 230 may include a number of portions having variousshapes and dimensions. It is also contemplated that alternatively knife215 can be provided in neck portion 220.

FIGS. 7A, 7B and 7C illustrate by way of example various configurationsof rods suitable for engaging a mounting mechanism (not shown) withinthe actuator 240 of the neck portion 220 of the magnetic compressionanastomosis device 200. Rods 701, 702 and 703 shown in FIGS. 7A, 7B and7C, respectively, include generally conical shaped mounting portions 760a, 760 b and 760 c, respectively. Each of the rods 701, 702 and 703 alsoincludes an annular recess 762 a, 762 b and 762 c, respectively, whichis correspondingly configured to be engaged by the mounting mechanism(such as flexible spring arms) within the actuator 240. For example, thespring arms can engage the recess and when pulled within the sleeveportion 260 are blocked from outward movement to thereby prevent releaseof the respective rod 701, 702 or 703.

FIGS. 4A, 4B, 5A and 5B illustrate anastomotic connectors according tovarious embodiments of the present disclosure. Each of the anastomoticconnectors shown in FIGS. 4A, 4B, 5A and 5B has a substantially annularring shape having a top surface, an inner diameter surface adjacent tothe top surface, an outer diameter surface adjacent to the top surface,and a bottom surface. It is to be understood that the shape and size ofthe anastomotic connectors may be varied from the exemplaryconfigurations depicted in FIGS. 4A, 4B, 5A and 5B. The terms top andbottom surfaces are used for convenience and reflect the orientation ofthe connectors of FIGS. 4A and 4B.

The anastomotic connectors shown in FIGS. 4A, 4B, 5A and 5B may eachinclude one or more materials, such as for example, magnetic andnonmagnetic materials. Each anastomotic connector includes a firstdimension “D1”, a second dimension “D2” and a third dimension “D3”,where D1 defines the outer diameter, D2 defines the inner diameter, andD3 defines the height (or thickness) of the connector, as shown in FIG.4A. (Only one of the connectors is labeled with “D” dimensions forclarity). It is to be understood that anastomotic connectors accordingto various embodiments of the presently disclosed magnetic compressionanastomosis device 200 may have any suitable dimensions D1, D2 and D3.The actual dimensions D1, D2 and D3 may depend on various factors, suchas for example, the size of the hollow organ sections to be treated, thedesired anastomosis procedure, and the materials used to form theanastomotic connectors.

Referring to FIGS. 4A and 4B, each of the first and second anastomoticconnectors 401, 402 has its north pole indicated by the letter “N” andits south pole indicated by the letter “S”. First and second anastomoticconnectors 401, 402 are each preferably formed substantially entirely ofa suitable magnetic material capable of producing a magnetic field. Inanother embodiment, at least one of the first anastomotic connector 401or the second anastomotic connector 402 includes portions of at leastone non-magnetic material. Examples of magnetic materials that may beused to form the first and second anastomotic connectors 401, 402include, but are not limited to, NdFeB (Neodymium Iron Boron), AlNiCo(Aluminum Nickel Cobalt) SmCo (Samarium Cobalt), strontium ferrite andbarium ferrite. In an alternate embodiment, one of the connectors wouldinclude material which produces a magnetic field and the other connectorwould be made of a material which reacts to the magnetic field, but doesnot necessarily produce a magnetic field, such as iron. It should beappreciated though that in the preferred embodiment both connectorsinclude magnetic material which produces a magnetic field which wouldincrease the attraction.

First anastomotic connector 401 has a generally annular body having atop surface 441, which corresponds to its south pole S, and a bottomsurface 461, which corresponds to its north pole N. The top and bottomsurfaces 441, 461 are generally flat and spaced apart by a suitabledistance D3. Although the top and bottom surfaces 441, 461 of the firstanastomotic connector 401 shown in FIG. 4A are generally flat, it is tobe understood that the top and bottom surfaces of anastomotic connectorsaccording to various embodiments may be non-flat, e.g. curved, or mayinclude a combination of flat, sloped or curved portions.

Second anastomotic connector 402 illustrated in FIG. 4B has a generallyannular body having a top surface 442, which corresponds to its southpole S, and a bottom surface 462, which corresponds to its North pole N.Second anastomotic connector 402 has a shape similar to that of thefirst anastomotic connector 401 shown in FIG. 4A, except the bottomsurface 462 of the second connector 402 has an anvil-like shape thatincludes flat, sloped and curved portions. Other shapes are alsocontemplated.

In a desired anastomosis procedure, the surgeon utilizes the magneticcompression anastomosis device 200 of FIG. 2 to deliver the first andsecond connectors 401, 402 (designated as 255, 265 in FIGS. 2 and 3) tothe respective end portions of the organ sections to be joined. In theinterests of clarity and simplicity, the first and second connectors255, 265 are hereinafter referred to as the first and second anastomoticconnectors 401, 402. However, it is to be understood that variousconfigurations of anastomotic connectors can be used for the first andsecond connectors, such as the exemplary anastomotic connectors shown inFIGS. 5A and 5B and FIGS. 6A through 6D. Procedures for the delivery ofthe head and neck portions 210, 220 carrying the first and secondanastomotic connectors 401, 402 to the end portions of the hollow organsto be joined are described later in this disclosure with reference toFIG. 8. After the delivery of the head and neck portions 210, 220, thesurgeon uses the magnetic compression anastomosis device 200 to deployaxially-aligned first and second anastomotic connectors 401, 402, asshown in FIGS. 9-11. As shown, the top surface (south pole) 441 ofconnector 401 (255) faces proximally and the bottom surface 462 (northpole) of connector 402 (265) faces distally. The magnetic attractionbetween opposite poles of the axially-aligned first and secondanastomotic connectors 401, 402 facilitates the formation of a reliableanastomosis. For example, in one instance, the magnetic attractionbetween the top surface 441 of the first anastomotic connector 401 andthe bottom surface 462 of the second anastomotic connector 402 maintainsthe two end portions of the organ sections in intimate contact with oneanother, forming a fluid-tight anastomosis.

In another embodiment (not shown), the first and second anastomoticconnectors 401, 402 are arranged in the magnetic compression anastomosisdevice 200 for delivery and deployment such that the bottom surface 461and top surface 462 of the first and second anastomotic connectors 401,402, respectively, are oriented towards each other. That is, the bottomsurface 461 of first connector 401 (255) faces proximally and the topsurface 442 of connector 402 (265) faces distally. In this instance,after the first and second anastomotic connectors 401, 402 are deployed,the magnetic attraction between opposite poles of the surfaces 461, 442maintain the two end portions of the organ sections in intimate contactwith one another, forming a fluid-tight anastomosis.

Thus, a pair of anastomotic connectors according to various embodimentscan be arranged in two orientations based on the magnetic polarities ofthe respective top and bottom surfaces. In instances where therespective top and/or bottom surfaces of a pair of anastomoticconnectors have different configurations, the surgeon is provided anincreased flexibility in performing a desired anastomosis procedure.

The amount of compression force exerted by the axially-aligned first andsecond anastomotic connectors 401, 402 on tissue of hollow organ wallportions to be joined will depend on various factors, including themagnetic materials used to form the first and second anastomoticconnectors 401, 402, the specific dimensions D1, D2 and D3 of the firstand second anastomotic connectors 401, 402, and thickness of tissue tobe joined.

FIGS. 5A and 5B illustrate first and second anastomotic connectors,according to another exemplary embodiment of the present disclosure.Although the first and second anastomotic connectors 501, 502 are shapedsimilar to the first and second anastomotic connectors 401, 402 shown inFIGS. 4A and 4B, respectively, the first and second anastomoticconnectors 501, 502 are annular four-pole configurations having four “N”and “S” magnetic poles. First and second anastomotic connectors 501, 502include one or more materials capable of producing a magnetic field,such as for example, NdFeB, AINiCo, SmCo, strontium ferrite, bariumferrite, or any combination thereof, and may include substantially rigidmaterials, such as for example, metal, synthetic or compound materials.Alternatively, one of the connectors 501, 502 can include one or morematerials capable of producing a magnetic field and the other connectorcan include one or more materials reactive to or affected by a magneticfield, such as iron.

Referring to FIG. 5A, the first anastomotic connector 501 includes fourfirst-type regions 510, 512, 514 and 516 and four second-type regions511, 513, 515 and 517, collectively together forming an annular body. Inan exemplary embodiment, the first-type regions 510, 512, 514 and 516are magnetic regions (with the poles as indicated) and the second-typeregions 511, 513, 515 and 517 are non-magnetic material regions. Forexample, in one instance, the non-magnetic material regions 511, 513,515 and 517 are individually arranged between the magnetic regions 510,512, 514 and 516 whereby the magnetic regions (of alternating polarity)are each separated from one another. Similarly, anastomotic connector502 has four first-type regions 521, 522, 524, 526 and four second-typeregions 531, 533, 535, 537, preferably magnetic and non-magneticmaterial, respectively, as described with respect to connector 501.Other arrangements of the north and south poles on the top surface arealso contemplated to achieve the function of magnetic attraction of therings. Alternatively, one of the connectors can have magnetic regionsthat produce a magnetic field and the other connector have magneticregions that react to the magnetic field.

The device of FIGS. 2, 2A and 3, with the handle and approximationmechanisms similar to FIG. 1, can be used to apply the connectors 501,502 to tissue. In use, after the delivery of the head and neck portions210, 220, the surgeon uses the magnetic compression anastomosis deviceto deploy axially-aligned first and second anastomotic connectors 501,502. The top surface 509 (as viewed in the orientation of FIG. 3A) ofconnector 501 faces proximally and the top surface 529 (as viewed in theorientation of FIG. 3A) of connector 502 faces distally. Rotation ofapproximation knob 22′ moves the connectors into approximation as rod 24o is pulled proximally. The magnetic attraction can release therespective connectors from the head portion 210 and neck portion 220, oralternatively handle 20′ can be pivoted relative to stationary handle18′ to advance a pusher (not shown) to advance the connector 265 fromneck portion 220.

The magnetic attraction between opposite poles of the first and secondanastomotic connectors 501, 502 facilitates the formation of a reliableanastomosis. That is, the magnetic attraction between the surfaces 509,529 of the first and second anastomotic connectors 501, 502 maintainsthe two end portions of the organ sections in intimate contact with oneanother, forming a fluid-tight anastomosis as the magnetic attractionapplies a clamping/holding force. The placement of alternating north andsouth poles on the facing surfaces minimizes rotation of the connectorswith respect to one another.

The amount of compression force exerted by the first and secondanastomotic connectors 501, 502 on the tissue of the hollow organ wallportions to be joined wills depend on various factors, including thematerials used to form the magnetic regions, the relative sizes of themagnetic and non-magnetic regions, and thickness of tissue to be joined.

In an alternate embodiment, an outer portion, e.g. an outer ringportion, of one connector has a first polarity and an inner portion,e.g. an inner ring portion, has a different polarity. The inner andouter portions of different polarities can occupy various areas of theconnector. The opposing connector would have inner and outer portions ofopposite polarity or of reactive material. This is shown for example inthe embodiment of FIG. 6A.

FIGS. 6A through 6D illustrate various embodiments of anastomoticconnector assemblies having inner and outer connector members. Referringfirst to FIG. 6A, the first anastomotic connector assembly 601 includesan outer connector member 610 and an inner connector member 615, theouter connector member 610 having an annular body that includes an innerdiameter wall 611 and the inner connector member 615 having an annularbody that includes an outer diameter wall 616. Similarly, the secondanastomotic connector assembly 602 includes an outer connector member630 and an inner connector member 635, the outer connector member 630having an annular body that includes an inner diameter wall 631 and theinner connector member 635 having an annular body that includes an outerdiameter wall 636. The outer diameter walls 616, 636 of the innerconnector members 615, 635 are dimensioned to fit within the innerdiameter walls 611, 631 of the outer connector members 610, 630,respectively, as shown in FIG. 6B.

In one embodiment, the inner connector members 615, 635 and the outerconnector members 610, 630 each include one or more magnetic materials.For example, the opposing surfaces of the inner members and the opposingsurfaces of the outer members can have opposite poles, arranged in acontinuous or in a spaced pattern (e.g. alternating pattern) on theindividual surface. In another embodiment, the inner connector members615, 635 each include one or more magnetic materials, and at least oneof the outer connector members 610, 630 includes one or morenon-magnetic materials. In yet another embodiment, the outer connectormembers 610, 630 each include one or more magnetic materials, and atleast one of the inner connector members 615, 635 includes one or morenon-magnetic materials. The poles in these embodiments can be arrangedon opposite surfaces of the assemblies 601, 602 (e.g. continuous) as inthe embodiment of FIG. 4A or arranged in spaced, e.g. alternating,fashion as in the embodiment of FIG. 5A, or arranged in other patterns.

First anastomotic connector assembly 601 can be constructed by placingthe inner connector member 615 within the inner diameter wall of theouter connector member 610, as indicated by the leftward arrows in FIG.6A. The outer diameter wall 616 of the inner connector member 615 mayinclude a number of attachment flanges and/or recesses (not shown) whichmay be configured to engage with correspondingly configured recessesand/or attachment flanges formed on the inner diameter wall 611 of theouter connector member 610, for example, to facilitate the positioningor securing of the inner and outer connector members 615, 610. Suchstructures can also be used to attach inner and outer connector members635, 630.

In one embodiment, the inner and outer connector members 615, 610 arepermanently bonded together, for example, using a suitable adhesive orother bonding agent. In another embodiment, the inner and outerconnector members 615, 610 are releasably attached to one another. Forexample, the inner and outer connector members 615, 610 may bereleasably attached using magnetic attraction, releasable adhesives,protrusions and/or recesses, or any combination thereof. Similar methodscan be used to connect inner and outer connector members 635, 630. Firstand second anastomotic connector assemblies 601, 602 shown in FIGS. 6Aand 6B can be constructed in a like fashion, and the two components ofconnector assembly 602 can be attached in any of the ways as describedfor connector assembly 601, and further description of attachment of thecomponents of the second anastomotic connector assembly 602 is omittedin the interests of brevity.

FIG. 6B illustrates organ wall portions of two hollow organs showing theaxially-aligned anastomotic connector assemblies 601, 602 of FIG. 6A. Atthe stage of an anastomosis procedure depicted in FIG. 6B, theanastomotic connector assemblies have been delivered and deployed andare shown axially-aligned along the centerline “A”. Referring to FIG.6B, the magnetic attraction between opposite poles on surfaces 617, 637of the inner connector members 615, 635 of the axially-alignedanastomotic connector assemblies 601, 602 maintains the tissue 621, 623in intimate contact with one another. Additionally, opposite poles (ofopposite polarity of the inner connector member positioned therein)could be provided on the facing surfaces of the outer connector members610, 630, to further maintain the tissue in intimate contact.

The anastomotic connector assemblies illustrated in FIGS. 6C and 6D aresimilar to the anastomotic connector assemblies shown in FIG. 6B, exceptthe outer connector members of the anastomotic connector assembliesshown axially-aligned along the centerline “A” in FIGS. 6C and 6D areadapted to provide an increased tissue-to-tissue contact area at theanastomosis site. An increased tissue-to-tissue contact area mayincrease strength, stability and tissue resiliency at the anastomosissite, which may reduce the risk of patients suffering an anastomoticleak.

Referring to FIG. 6C, the outer diameter wall of each of the outerconnector members 612, 637 includes a protrusion 618′, 638′ configuredto produce an increased surface area of tissue 621, 623 maintained inintimate contact, as compared to the outer connector members 610, 630shown in FIG. 6B. The protrusion on the outer connector members 612, 637results in an increased contact area between the tissue 621, 623 of theorgan wall portions to be joined at the point “P2” in FIG. 6C, ascompared to that at point “P1” in FIG. 6B, because the protrusion isadvantageously shaped to reduce the angle of separation between thetissue 621, 623 at the point “P2”, as compared to point “P1”, when theanastomotic connector assemblies are axially-aligned.

Another embodiment of outer connector members adapted to provide anincreased tissue-to-tissue contact area at the anastomosis site when theanastomotic connector assemblies are axially-aligned is shown in FIG.6D. Referring to FIG. 6D, the protrusion on the outer connector members614, 639 is advantageously shaped to reduce the angle of separationbetween the tissue 621, 623 of the organ wall portions to be joined atthe point “P3”, as compared to that at the point “P1” in FIG. 6B, whichresults in an increased contact area between the tissue 621, 623 at thepoint “P3”. Also, the outer surface of the connector members 614 and 639has curves as shown. It is to be understood that the shape and size ofthe outer connector members may be varied from the exemplaryconfigurations depicted in FIGS. 6C and 6D.

In an anastomosis procedure, the surgeon separately delivers the headand neck portions 210, 220 of the magnetic compression anastomosisdevice 200 into the end portions of first and second hollow organs. FIG.8 illustrates the head and neck portions 210, 220 separately deliveredto first and second hollow organs according to an exemplary embodiment.Referring to FIG. 8, after the insertion of the head portion 210 intothe first hollow organ, a purse string suture 822 is used to pull theorgan wall portion 821 towards the rod 230. After the insertion of theneck portion 220 of the instrument 200 into the second hollow organ, apurse string suture 824 is used to pull the organ wall portion 823towards the center rod 824 (similar to the center rod 240 of FIG. 2A).Although purse string sutures 822, 824 are used in the embodimentillustrated in FIG. 8, it is to be understood that any suitable means ofsecuring the organ wall portions 821, 823 to the rod 230 and rod 240,respectively, may be utilized. The rods are then mated as describedabove and the head and neck portions 210, 220 approximated as describedabove (e.g. by rotation knob retracting the center rod), followed bydeployment of the connectors (e.g. by magnetic attraction releasing theconnectors as they move a sufficient distance toward each other or by apusher ejecting the connector in the neck portion 22). The variousembodiments of the connectors described herein can be placed in the samemanner.

FIGS. 9-11 are cross-sectional views of the magnetic compressionanastomosis device illustrated in FIGS. 2 and 3 showing deployment ofthe anastomotic connectors, according to an exemplary embodiment of thepresent disclosure. Referring to FIG. 9, the head portion 210 is mountedto the neck portion 220 by inserting a mounting portion of the rod 230within the actuator (center rod) 240 so that a mounting mechanism withinthe actuator 240 securely engages the rod 230. To “fire” the magneticcompression anastomosis device 200, the actuator 240, including theattached head portion 210, is retracted into the neck portion 220 (byuse of an approximation knob 22′ similar to knob 22 of FIG. 1 by way ofexample), pulling in the two organ wall portions 821, 823 into closeapproximation, whereupon magnetic attraction between the axially-alignedanastomotic connectors 401, 402 takes hold, releasing them from theinstrument due to the magnetic force and thereby providing a compressionforce that maintains the organ wall portions 821, 823 in intimatecontact. Alternatively, as described above, a pusher can be utilized,actuated by handle 20′.

Referring to FIG. 10, as the head portion 210 is retracted into the neckportion 220, an annular knife 215 (shown in FIG. 3) is pulled throughtissue. (Note the edge 216 of the knife-can be shielded by the connector255 as shown in FIG. 3). Alternatively, the annular knife could bepositioned in the neck portion 220 and advanced by a separate knifeadvancing mechanism (not shown) to core tissue within the hollow organcontaining the purse strings 822, 824 to create a tubular passage withinthe organ. The knife advancing mechanism can be actuated for example byhandle 20′ of instrument 200. Referring to FIG. 11, the first and secondanastomotic connectors 401, 402 are shown axially aligned along thecenterline “A”, producing a reliable anastomosis that places the firstand second hollow organs in flow communication. The head and neckportions 210, 220 of the magnetic compression anastomosis device 200 areremoved from the patient's body. The magnetic compression anastomosisdevice 200 could be easily reloaded with connecting members, if desired,and fired several times on the same patient.

With time, such as several days, the tissue under a ring of modestpressure begins to heal. The tissue under severe pressure begins tonecrose and die, allowing the first and second anastomotic connectors401, 402 to fall free and naturally pass out of the body, as shown inFIG. 12. Accordingly, in a preferred embodiment, no foreign materialsare left permanently in the patient's body.

Although embodiments have been described in detail with reference to theaccompanying drawings for the purpose of illustration and description,it is to be understood that the inventive processes and apparatus arenot to be construed as limited thereby. It will be apparent to those ofordinary skill in the art that various modifications to the foregoingexemplary embodiments may be made without departing from the scope ofthe disclosure.

What is claimed is:
 1. An apparatus for joining organ walls of first andsecond hollow organs, comprising: a first connector; a second connectordefining a cavity, the first and second connectors magneticallyattracted to one another; and a device for delivering and deploying thefirst and second connectors to the first and second hollow organs, thedevice including a first portion and a second portion, the secondportion sized to pass through the first and second connectors, the firstportion releasably housing the second connector at a distal end thereofand the second portion releasably affixed to the first connector, thesecond portion including a cutting edge facing the first portion andconfigured to pass through the cavity of the second connector, whereinthe first portion includes an actuator that is releasably engageablewith the second portion and is moveable between a first position inwhich disengagement of the second portion from the actuator is allowedand a second position in which disengagement of the second portion fromthe actuator is prevented.
 2. The apparatus of claim 1, wherein at leastone of the first and second connectors produces a magnetic field.
 3. Theapparatus of claim 1, wherein each of the first and second connectorsproduces a magnetic field.
 4. The apparatus of claim 1, wherein thecutting edge is configured to core tissue within the cavity.
 5. Theapparatus of claim 1, wherein the cutting edge is disposed on an outerdimension of the second portion.
 6. The apparatus of claim 5, whereinthe cutting edge is annular.
 7. The apparatus of claim 5, wherein thecutting edge defines a diameter less than a diameter defined by thecavity.
 8. The apparatus of claim 1, wherein the second portion includesa proximally extending rod received by the first portion.
 9. Theapparatus of claim 1, wherein the second portion includes a rod, the rodof the second portion being releasably engagable with the actuator. 10.The apparatus of claim 1, wherein the second portion includes a rod, therod of the second portion being slidably engagable with the actuatorsuch that as the device is actuated, the rod approximates the first andsecond portions together to bring the first and second connectors intoclose approximation with one another, wherein the magnetic attractionbetween the first and second connectors applies a compressive force totissue captured therebetween.
 11. The apparatus of claim 1, wherein thefirst and second connectors define annular bodies.
 12. The apparatus ofclaim 1, wherein at least one of the first and second connectorsincludes a protrusion on a surface facing the other one of the first andsecond connectors.
 13. The apparatus of claim 1, wherein at least one ofthe first and second connectors includes an inner connector member andan outer connector member.